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Terminated

SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US

FDA Recall Z-0035-2007 · Posted 2006-10-12

Recalling FirmHaemonetics Corporation
Recall StatusTerminated
Product CodeBTA
Date Initiated2006-07-28
Date Terminated2006-10-24
Product Quantity15 units

Reason for Recall

Faulty circuit board may short circuit and cause electric shock to operator

Firm Action

Haemonetics issued recall leters on July 28, 2006 via Certified Mail, Return Receipt. Users are requested to return unit for repair or replacement.

Root Cause

Other

Distribution Pattern

AZ, CT, GA, NE, MS Austria, France, Taiwan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052626SMARTSUCTION HARMONY DEVICEHaemonetics Corp. · 2005-10-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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